56388 Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and Regulations 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 18, 2006. 

James Jones, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.617 is added to read as 

follows: 

§ 180.617 Metconazole; tolerances for 

residues. 

(a) General. Tolerances are 

established for the residue of the 

fungicide metconazole (5-[(4- 

chlorophenyl)methyl]-2,2-dimethyl-1- 

(1H-1,2,4-triazol-1- 

ylmethyl)cyclopentanol) in or on the 

following commodity: 

Commodity Parts per million 

Banana1 ................ 0.1 

1 No U.S. registration as of August 30, 2006. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 06–8256 Filed 9–26–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0058; FRL–8091–5] 

Ethaboxam; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of ethaboxam in 

or on grape at 6.0 parts per million 

(ppm), with no U.S. registration. Landis 

International, Inc., agent for LG Life 

Sciences, Ltd. requested this tolerance 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA). 

DATES: This regulation is effective 

September 27, 2006. Objections and 

requests for hearings must be received 

on or before November 27, 2006, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2005–0058. All documents in the 

docket are listed in the index for the 

docket. Although listed in the index, 

some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. 

S–4400, One Potomac Yard (South 

Building), 2777 S. Crystal Drive, 

Arlington, VA. The Docket Facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The Docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Bryant Crowe, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–0025; e-mail address: 

crowe.bryant@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides a guide 


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for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2005–0058 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before November 27, 2006. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2005–0058, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Building), 2777 S. 

Crystal Drive, Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of July 6, 2005 

(70 FR 38918) (FRL–7719–3), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 4E6863) by LG 

Life Sciences, Ltd., c/o Landis 

International, Inc., P.O. Box 5126, 

Valdosta, GA 31603–5126. The petition 

requested that 40 CFR 180.622 be 

amended by establishing a tolerance for 

residues of the fungicide ethaboxam, N- 

(cyano-2-thienylmethyl)-4-ethyl-2- 

(ethlyamino)-5-thiazolecarboxamide, in 

or on grape, grape juice, and raisins at 

6.0 ppm. That notice included a 

summary of the petition prepared by the 

registrant LG Life Sciences, Ltd., c/o 

Landis International, Inc. There were no 

comments received in response to the 

notice of filing. 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 

FFDCA and a complete description of 

the risk assessment process, see http:// 

www.epa.gov/oppfead1/trac/science. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action. EPA has sufficient data to assess 

the hazards of and to make a 

determination on aggregate exposure, 

consistent with section 408(b)(2) of 

FFDCA, for a tolerance for residues of 

ethaboxam on grape at 6.0 ppm. Studies 

examining the transfer of ethaboxam to 

processed grape commodities (e.g., 

grape juice, raisins) show that some 

concentration of ethaboxam may occur 

during the production of raisins and 

grape juice; however, the supported 

tolerance of 6.0 ppm for grape is 

sufficient to cover the potential for 

residues in the processed commodities, 

and separate tolerances for these 

commodities are not needed. EPA’s 

assessment of exposures and risks 

associated with establishing the 

tolerance follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the toxic effects caused by 

ethaboxam as well as the no observed 

adverse effect level (NOAEL) and the 

lowest observed adverse effect level 

(LOAEL) from the toxicity studies can 

be found in the electronic docket 

(docket ID number EPA–HQ–OPP–

2005–0058) for this rule at http:// 

www.regulations.gov or http:// 

www.epa.gov/opprd001/factsheets. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the dose at which no adverse 

effects are observed (the NOAEL) from 

the toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect uncertainties inherent 


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in the extrapolation from laboratory 

animal data to humans and in the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

cancer risk, estimates risk in terms of 

the probability of occurrence of 

additional cancer cases. More 

information can be found on the general 

principles EPA uses in risk 

characterization at http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm and 

http://www.epa.gov/oppfead1/trac/ 

science. 

A summary of the toxicological 

endpoints for ethaboxam used for 

human risk assessment is shown in 

Table 1. of this unit: 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR ETHABOXAM FOR USE IN HUMAN RISK ASSESSMENT

Exposure/Scenario 

Dose Used in Risk Assessment, Interspecies and 

Intraspecies and any Traditional UF 

Special FQPA SF and 

Level of Concern for Risk 

Assessment 

Study and Toxicological Effects 

Acute Dietary (Females 13–49 

years of age) 

NOAEL = 30 mg/kg/day 

UF = 100 

Acute RfD = 0.3 mg/kg/day 

Special FQPA SF = 1 

aPAD = acute RfD/Special 

FQPA SF = 0.3 mg/kg/ 

day 

Developmental Toxicity Rat LOAEL = 100 mg/ 

kg/day based on abnormal liver lobation 

Acute Dietary (General population including infants and 

children) 

NOAEL = N/A 

UF = N/A 

Acute RfD = N/A 

Special FQPA SF = N/A 

aPAD = acute RfD/Special 

FQPA SF = N/A 

No appropriate endpoint attributable to a single dose identified. LOAEL = N/A 

Chronic Dietary (All populations) NOAEL= 5.5 mg/kg/day 

UF = 100 

Chronic RfD = 0.055 mg/kg/ 

day 

Special FQPA SF = 1 

cPAD = chronic RfD/Special FQPA SF = 0.055 

mg/kg/day 

Combined Chronic/Carcinogenicity-Rat LOAEL 

= 16.4 mg/kg/day based on effects observed 

in the male reproductive organs (testes, 

epididymides, prostate, and seminal vesicles). 

Cancer (oral, dermal, inhalation) N/A N/A The Agency classified ethaboxam as having 

‘‘suggestive evidence of carcinogenicity.’’

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Risk assessments were 

conducted by EPA to assess dietary 

exposures from ethaboxam in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a one-day or 

single exposure. No such effects were 

identified in the toxicological studies 

for ethaboxam that pertain to the general 

population including infants and 

children; however, an effect of concern 

was identified for females, 13–49 years 

of age. Therefore, a quantitative acute 

dietary exposure assessment was 

necessary for females, 13–49 years of 

age. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

(DEEM-FCIDTM), which incorporates 

food consumption data as reported by 

respondents in the USDA 1994–1996 

and 1998 Nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII), and accumulated exposure to 

the chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessment: 

Chronic dietary analysis is based on the 

tolerance level residues and an 

assumption that 100% of the crop will 

be treated. 

iii. Cancer. The Agency classified 

ethaboxam as having ‘‘suggestive 

evidence of carcinogenicity.’’ The 

Agency concluded that the 

quantification of carcinogenic potential 

is not required. 

2. Dietary exposure from drinking 

water. This petition is not associated 

with an application to register 

ethaboxam uses in the U.S. Ethaboxam 

is proposed for use on fruit commodities 

that may be imported into the U.S., 

thus, the source of exposure expected 

for ethaboxam is solely from residues in 

food. Consequently, an exposure 

assessment that includes ethaboxam 

residues in drinking water is not 

warranted at this time. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Ethaboxam is not registered for use on 

any sites that would result in residential 

exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

ethaboxam and any other substances 

and ethaboxam does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

not assumed that ethaboxam has a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 


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D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base on 

toxicity and exposure unless EPA 

determines based on reliable data that a 

different margin of safety will be safe for 

infants and children. Margins of safety 

are incorporated into EPA risk 

assessments either directly through use 

of a MOE analysis or through using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk to humans. In applying 

this provision, EPA either retains the 

default value of 10X when reliable data 

do not support the choice of a different 

factor, or, if reliable data are available, 

EPA uses a different additional safety 

factor value based on the use of 

traditional uncertainty factors and/or 

special FQPA safety factors, as 

appropriate. 

2. Prenatal and postnatal sensitivity. 

There is evidence of increased 

qualitative susceptibility in the rat 

developmental and reproduction 

studies. Considering the overall toxicity 

profile and the doses and endpoints 

selected for risk assessment for 

ethaboxam, the degree of concern for 

prenatal and postnatal effects observed 

in the studies is low based on the 

following: The developmental/offspring 

effects observed in the studies are well 

characterized and occur in the presence 

of maternal toxicity; a clear NOAEL has 

been identified in both of the studies; 

and there are no residual uncertainties 

for pre-and/or postnatal toxicity. 

Furthermore, the toxicology endpoint 

established for risk assessment is based 

on a lower NOAEL than the 

reproductive NOAEL, and thus is 

considered protective of developmental/ 

offspring effects. 

3. Conclusion. The Agency 

recommends that the FQPA safety factor 

be reduced to 1X because there are no/ 

low concerns and no residual 

uncertainties with regard to pre- and 

post-natal toxicity. Although there was 

evidence of increased qualitative 

susceptibility observed in rat 

developmental and reproduction 

studies, the studies submitted 

adequately address questions regarding 

pre- and post- natal toxicity, and the 

developmental/offspring effects 

observed in the studies are well 

characterized (clear NOAELs 

established). The toxicology endpoint 

established for risk assessment is based 

on a lower NOAEL than the 

reproductive NOAEL, and is considered 

protective of the developmental/ 

offspring effects observed. In addition, 

the toxicology endpoint established for 

risk assessment is also considered 

protective of the male reproductive 

alterations observed in the toxicology 

database. There is a complete toxicity 

database for ethaboxam and exposure 

data are complete or are estimated based 

on data that reasonably accounts for 

potential exposures. 

E. Aggregate Risks and Determination of 

Safety 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food to ethaboxam will 

occupy 10% of the aPAD for the U.S. 

population and 4% of the aPAD for 

females 13 years and older. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to ethaboxam from food 

will utilize 6% of the cPAD for the U.S. 

population, 9% of the cPAD for all 

infants less than 1 year of age, and 31% 

of the cPAD for children 1–2 years of 

age. There are no residential uses for 

ethaboxam that result in chronic 

residential exposure to ethaboxam. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Ethaboxam is not registered for use on 

any sites that would result in residential 

exposure or residues in drinking water. 

Therefore, the aggregate risk is the sum 

of the risk from food only, which does 

not exceed the Agency’s level of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Ethaboxam is not registered for use on 

any sites that would result in residential 

exposure or residues in drinking water. 

Therefore, the aggregate risk is the sum 

of the risk from food only, which does 

not exceed the Agency’s level of 

concern. 

5. Aggregate cancer risk for U.S. 

population. The Agency classified 

ethaboxam as having ‘‘suggestive 

evidence of carcinogenicity based on 

Leydig cell tumors observed in male 

rats.’’ The Agency has determined that 

potential human risk to Leydig cell 

tumorigenesis would not be expected at 

exposure levels that do not cause 

tumors in rats. The NOAEL and LOAEL 

selected for the chronic reference dose 

(cRfD) is based on reproductive toxicity 

observed at lower doses than the Leydig 

cell tumor response. Thus, the cRfD 

would be protective of the cancer 

effects. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, and to infants and children 

from aggregate exposure to ethaboxam 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(HPLC/MS) is available to enforce the 

tolerance expression. The method may 

be requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are currently no established 

Codex, Canadian, or Mexican maximum 

residue levels (MRLs) for ethaboxam. 

V. Conclusion 

Therefore, an imported tolerance is 

established for residues of ethaboxam, 

N-(cyano-2-thienylmethyl)-4-ethyl-2- 

(ethylamino)-5-thiazolecarboxamide, in 

or on grape at 6.0 ppm. Studies 

examining the transfer of ethaboxam to 

processed grape commodities (e.g., 

grape juice, raisins) show that some 

concentration of ethaboxam may occur 

during the production of raisins and 

grape juice; however, the supported 

tolerance of 6.0 ppm for grape is 

sufficient to cover the potential for 

residues in the processed commodities, 

and separate tolerances for these 

commodities are not needed. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). This final rule does not 

contain any information collections 


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subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., or impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). Nor does it require any 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

Agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 13, 2006. 

James Jones, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR part 180 is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.622 is added to read as 

follows: 

§ 180.622 Ethaboxam; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of ethaboxam, 

N-(cyano-2-thienylmethyl)-4-ethyl-2- 

(ethlyamino)-5-thiazolecarboxamide in 

or on the following commodity: 

Commodity Parts per 

million 

Grape1 ...................................... 6.0 

1 There is no U.S. registration as of September 27, 2006 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 06–8176 Filed 9–26–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0036; FRL–8089–6] 

p-Chlorophenoxyacetic acid, 

Glyphosate, Difenzoquat, and 

Hexazinone; Tolerance Actions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is revoking certain 

tolerances for the plant growth regulator 

p-chlorophenoxyacetic acid and the 

herbicide hexazinone. Also, EPA is 

modifying certain tolerances for the 

plant growth regulator pchlorophenoxyacetic acid and the 

herbicides glyphosate, difenzoquat, and 

hexazinone. In addition, EPA is 

establishing new tolerances for the 

herbicides difenzoquat and hexazinone. 

DATES: This regulation is effective 

September 27, 2006. Objections and 

requests for hearings must be received 

on or before November 27, 2006, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2006–0036. All documents in the 

docket are listed in the index for the 

docket. Although listed in the index, 

some information is not publicly 

available, e.g., Confidential Business 


sroberts on PROD1PC70 with RULES